A Concurrent Non-Randomized Controlled Trial on Integrated Traditional Chinese and Western Medicine for Patellar Dislocation Pain
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 80
- 试验地点
- 1
研究概览
简要总结
This study is a concurrent non-randomized controlled pilot trial. We plan to recruit 80 patients following patellar dislocation surgery from Peking University Third Hospital in China, with at least 40 participants in each group. The study aims to evaluate the safety and efficacy of acupuncture for the treatment of postoperative pain after patellar dislocation. The treatment regimen (pharmacological therapy or acupuncture) will be determined by the clinician and the patient based on the patient's condition and preference.
Participants will be assigned to two groups according to the treatment they receive in clinical practice: a medication group and an acupuncture group. All participants will enter a follow-up phase lasting up to 3 months.
Assessments include pain intensity (Visual Analog Scale, VAS), the Lysholm Knee Score, the International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form, the Tegner Activity Score, a sleep score, and the degree of joint swelling. VAS pain score, sleep score, and joint swelling will be evaluated preoperatively and on postoperative days 3, 4, 7, 14, 30, and at 3 months. The remaining outcomes will be measured at 3 months postoperatively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with recurrent patellar dislocation, male or female;
- •patients with acute patellar dislocation complicated by a tangential osteochondral fracture requiring surgical treatment;
- •patients who voluntarily participated in the clinical trial, signed the informed consent form, and were able to comply with clinical follow-up;
排除标准
- •participation in other drug or medical device clinical trials within the past 6 months;
- •joint fibrosis, ankylosis, or significant limitation of movement;
- •contraindications to MRI examination;
- •other conditions that, in the physician's judgment, preclude participation in the trial.
研究者
Liu Zhenlong
Associate Chief Physician
Peking University Third Hospital
